Cai, G and Laslett, LL and Aitken, D and Cicuttini, F and March, L and Hill, C and Winzenberg, T and Jones, G, Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial, Therapeutic Advances in Musculoskeletal Disease, 11 pp. 1-12. ISSN 1759-720X (2019) [Refereed Article]
© The Author(s), 2019. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/
Methods: A single-center, double-blind, randomized controlled trial (RCT) was carried out. Adults (aged ⩾50 years) with knee osteoarthritis, significant knee pain [⩾40 mm on a 100 mm visual analog scale (VAS)], and magnetic resonance imaging-detected bone marrow lesion (BML) were randomized to receive a one-off administration of VOLT01, ZA, or placebo. The primary hypothesis was that VOLT01 was superior to ZA in having a lower incidence of acute phase responses (APRs) over 3 days. Secondary hypotheses were that VOLT01 was noninferior to ZA, and both treatments were superior to placebo in decreasing BML size over 6 months and in improving knee pain [Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and VAS] and function (WOMAC) over 3 and 6 months.
Results: A total of 117 patients (62.2 ± 8.1 years, 63 women) were enrolled. The incidence of APRs was similar in the VOLT01 (90%) and ZA (87%) groups (p = 0.74). VOLT01 was superior to ZA in improving knee pain and function after 6 months and noninferior to ZA in reducing BML size. However, BML size change was small in all groups and there were no between-group differences. Compared with placebo, VOLT01 but not ZA improved knee function and showed a trend toward improving knee pain after 6 months.
Conclusions: Administering intravenous methylprednisolone with ZA did not reduce APRs or change knee BML size over 6 months, but in contrast to ZA or placebo, it may have a beneficial effect on symptoms in knee osteoarthritis.
|Item Type:||Refereed Article|
|Keywords:||acute phase response, bone marrow lesion, methylprednisolone, noninferiority, zoledronic acid|
|Research Division:||Medical and Health Sciences|
|Research Group:||Clinical Sciences|
|Research Field:||Rheumatology and Arthritis|
|Objective Group:||Clinical Health (Organs, Diseases and Abnormal Conditions)|
|Objective Field:||Skeletal System and Disorders (incl. Arthritis)|
|UTAS Author:||Cai, G (Mr Guoqi Cai)|
|UTAS Author:||Laslett, LL (Dr Laura Laslett)|
|UTAS Author:||Aitken, D (Associate Professor Dawn Aitken)|
|UTAS Author:||Winzenberg, T (Professor Tania Winzenberg)|
|UTAS Author:||Jones, G (Professor Graeme Jones)|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||4 View Download Statistics|
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